a phase i multicenter clinical trial to evaluate the safety and immunogenicity of immuno-ag recombinant hiv gp160 in asymptomatic hiv seropositive individuals

Conditions: HIV Infections

Summary: to determine the safety and immunogenicity of vaccinia-derived hiv-1 recombinant envelope glycoprotein (gp160) in asymptomatic hiv-infected adult volunteers. to compare safety and immunogenicity of two different schedules of gp160 administration. to examine the effects of gp160 and hepatitis b vaccine (engerix-b) on various markers of viral load and on selected immune parameters. potentiation of a patient's immune response to hiv might possibly prolong the period of clinical latency and protect the patient indefinitely. preliminary results from a study of immuno-ag recombinant gp160 vaccine in healthy volunteers not infected with hiv suggest that the vaccine is safe and produces antibodies against the virus. because another previous study failed to demonstrate a specific anti-hiv response in patients injected with a recombinant vaccinia virus containing hiv-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis b vaccination) that would be expected to induce a nonspecific immune response in hiv-infected persons.

potentiation of a patient's immune response to hiv might possibly prolong the period of clinical latency and protect the patient indefinitely. preliminary results from a study of immuno-ag recombinant gp160 vaccine in healthy volunteers not infected with hiv suggest that the vaccine is safe and produces antibodies against the virus. because another previous study failed to demonstrate a specific anti-hiv response in patients injected with a recombinant vaccinia virus containing hiv-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis b vaccination) that would be expected to induce a nonspecific immune response in hiv-infected persons. fifty-five healthy hiv-positive volunteers are randomly assigned to one of the following treatment arms: six injections (arm i) or four injections (arm ii) of hiv-1 gp160 vaccine, four injections of hepatitis b vaccine as a non-hiv viral vaccine control (arm iii), or six placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine (arm iv). immunizations or placebo are given at 4-week intervals for 5 months. to maintain blinding, adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving four instead of six vaccine injections (arms ii and iii). volunteers are followed at 4-month intervals for 2 years.

Eligibility criteria:
inclusion criteria concurrent medication: recommended: * prophylaxis with isoniazid in patients not previously treated. patients must have: * hiv seropositivity by western blot. * normal history and physical exam (generalized lymphadenopathy is acceptable). * mean cd4 cell count = or \> 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count \< 450 cells/mm3. * negative ppd test or normal chest x-ray with positive ppd (induration = or \> 5 mm). exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * hepatitis b surface antigen positive. * evidence of an aids- or arc-defining opportunistic infection. * evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month. * active syphilis. patients with the following prior conditions are excluded: * evidence of psychiatric disorder within the past year that would impair adherence to the protocol. * history of an aids- or arc-defining opportunistic infection. * history of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month. prior medication: excluded: * immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening. * immunosuppressive medications within the previous 3 months. * zidovudine (azt) or any antiviral agent (including interferon) within the previous 6 months. * vaccination against other pathogens within 4 weeks of initial screening laboratory work. use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.

Keywords: vaccines, synthetic vaccinia virus viral vaccines hiv-1 hiv envelope protein gp160 acquired immunodeficiency syndrome aids-related complex aids vaccines hiv therapeutic vaccine